Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion

NCT07726784 | Not Yet Recruiting

• 1 other identifier: JEP-2026-204
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Pleural effusion is a common problem in hospital patients. It may arise from a wide range of diseases. There is a multitude of recognised causes of pleural effusion, and in addition, other pleural conditions such as pleural thickening and pneumothorax represent a significant burden to the healthcare system and to patients. However, the diagnosis of this condition may sometimes be difficult. In pleural effusions undiagnosed by thoracocentesis, closed pleural biopsy provides limited yield, whereas the diagnostic yield of thoracoscopy is substantially higher for both malignant and tuberculous pleural effusions. Hence, medical thoracoscopy (MT) (pleuroscopy) is the gold standard in the diagnosis of pleural effusion and it is indicated when less invasive tests have failed. MT is a procedure in which the pleura is directly and visually examined. An endoscope is inserted into the intercostal space by creating a pneumothorax with an incision through the chest wall. The pleural space and its lining can be inspected and therapeutic interventions performed. There are two different techniques that can be performed for diagnostic and therapeutic thoracoscopy. One method recommends a single-entry site, the use of a rigid thoracoscope (or of a semi-rigid/semi-flexible pleuroscope) with a working channel for accessory instruments and an optical biopsy forceps, both performed under local anaesthesia. The other method requires two entry sites: one for a trocar for the examination telescope, and the second for accessory instruments including the biopsy forceps, and is usually performed with conscious sedation or general anaesthesia. In the trained hands of a pulmonologist, MT is a safe and effective procedure for diagnosing and treating multiple pleural diseases. The unfamiliarity of the pulmonary physician with rigid instruments and familiarity with the flexible bronchoscope has led various investigators to attempt thoracoscopy with flexible endoscopes. Flexible instruments allow concurrent suctioning to maintain a clear optical field, providing good views at the apex and paravertebral gutters. This method is considered useful for physicians with experience in chest drainage and flexible bronchoscopy, as well as safe and well tolerated with a minimal degree of discomfort and expense.

Conditions

Malignant Pleural Effusions (Mpe); Medical Thoracoscopy; Pleural Effusion

Keywords

PLEURAL EFFUSION; MEDICAL THORACOSCOPY

Outcome Measures

Primary Outcomes (1)

• Feasibility rate (in percentage) of medical thoracoscopy using a single-use flexible bronchoscope compared with the conventional semi-rigid pleuroscope

  Reported as a single percentage: the proportion of trial cases meeting 100% of defined feasibility criteria. Individual measures (recruitment consent, intervention delivery, protocol adherence, technical pleural entry including visualization and biopsy, procedural completion without crossover, and 48-hour follow-up) will be evaluated per participant. The final reported value is calculated as: Overall Feasibility Rate (%)= Number of participants meeting all 7 feasibility criteria ÷ Total number of enrolled participants X 100%

  Baseline up to 48 hours post-procedure

Secondary Outcomes (5)

• Difference in procedure duration (in minutes) between the single-use flexible bronchoscope and the conventional semi-rigid pleuroscope to evaluate time-efficiency.

  During the procedure (From 30 to 60 minutes)

• Procedural success rate (in percentage) between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope

  During the procedure (approximately 30 to 60 minutes)

• Difference in immediate procedural and disposable hardware costs between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope

  During procedure execution (up to 2 hours)

• Diagnostic Yield Rate (in percentage) between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope

  From time of procedure through final pathology report release (up to 14 days post-procedure)

• Incidence of Immediate Treatment-Related Adverse Events Within 48 Hours between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope

  Baseline up to 48 hours post-procedure

Study Arms (2)

Semi-Rigid Pleuroscope

ACTIVE COMPARATOR

The comparator device is the Olympus LTF-260 Semi-Rigid Pleuroscope, which represents the current standard-of-care instrument used for medical thoracoscopy at Hospital Canselor Tuanku Muhriz (HCTM) UKM. The semi-rigid pleuroscope features a flexible distal tip and a 2.8-mm working channel, enabling visualization of the pleural cavity and tissue acquisition during pleural biopsy.

Device: Semi-Rigid Pleuroscope

Single-Use Flexible Bronchoscope

EXPERIMENTAL

The investigational device evaluated in this study is the UE Medical Single-Use Flexible Bronchoscope, a sterile disposable flexible endoscope equipped with a 2.8-mm working channel. The device is designed to visualize the pleural cavity and permit pleural tissue sampling with standard biopsy forceps during medical thoracoscopy.

Device: Single-Use Flexible Bronchoscope

Interventions

Single-Use Flexible Bronchoscope DEVICE

The investigational device evaluated in this study is the UE Medical Single-Use Flexible Bronchoscope, a sterile disposable flexible endoscope equipped with a 2.8-mm working channel. The device is designed to visualize the pleural cavity and permit pleural tissue sampling with standard biopsy forceps during medical thoracoscopy. Both devices are intended to achieve the same clinical objectives, namely pleural cavity inspection and pleural tissue sampling. The primary difference is that the investigational device is a single-use, disposable, flexible bronchoscope, whereas the comparator is a reusable, semi-rigid pleuroscope routinely used in clinical practice.

Single-Use Flexible Bronchoscope

Semi-Rigid Pleuroscope DEVICE

The comparator device is the Olympus LTF-260 Semi-Rigid Pleuroscope, which represents the current standard-of-care instrument used for medical thoracoscopy at Hospital Canselor Tuanku Muhriz (HCTM) UKM. The semi-rigid pleuroscope features a flexible distal tip and a 2.8-mm working channel, enabling visualization of the pleural cavity and tissue acquisition during pleural biopsy. Both devices are intended to achieve the same clinical objectives, namely pleural cavity inspection and pleural tissue sampling. The primary difference is that the investigational device is a single-use, disposable, flexible bronchoscope, whereas the comparator is a reusable, semi-rigid pleuroscope routinely used in clinical practice.

Semi-Rigid Pleuroscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Patient presents with an undifferentiated pleural effusion with or without initial diagnostic thoracocentesis, thereby necessitating definitive pleural tissue sampling.
• Demonstrated presence of a visually significant pleural effusion occupying at least one-third of the affected hemithorax on standard chest radiography, or a visually confirmed loculated effusion accessible via thoracic ultrasound mapping.
• The patient has demonstrated full willingness to participate and has signed the formal written informed consent form approved by the institutional review board.

You may not qualify if:

• Age \< 18 years
• Patients with contraindications to perform medical thoracoscopy, e.g.:
• Uncorrectable coagulopathy (e.g., platelet count \<50,000/µL, INR \>1.5 despite correction)
• Severe hypoxemia not correctable with supplemental oxygen
• Hemodynamic instability
• Extensive pleural adhesions or obliterated pleural space on imaging
• Uncontrolled cardiac arrhythmia or recent acute coronary syndrome
• Severe pulmonary hypertension with high procedural risk
• Inability to tolerate lateral decubitus position
• Refusal to provide informed consent
• Pregnancy
• Previous ipsilateral pleurodesis or thoracic surgery significantly altering pleural anatomy

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz, National University of Malaysia,

Cheras, Kuala Lumput, 56000, Malaysia

Location

Related Publications (16)

• Rozman A, Camlek L, Marc-Malovrh M, Triller N, Kern I. Rigid versus semi-rigid thoracoscopy for the diagnosis of pleural disease: a randomized pilot study. Respirology. 2013 May;18(4):704-10. doi: 10.1111/resp.12066.

  PMID: 23418922 BACKGROUND

• Gwin E, Pierce G, Boggan M, Kerby G, Ruth W. Pleuroscopy and pleural biopsy with the flexible fiberoptic bronchoscope. Chest. 1975 May;67(5):527-31. doi: 10.1378/chest.67.5.527.

  PMID: 1126188 BACKGROUND

• Senno A, Moallem S, Quijano ER, Adeyemo A, Clauss RH. Thoracoscopy with the fiberoptic bronchoscope. A simple method in diagnosing pleuropulmonary diseases. J Thorac Cardiovasc Surg. 1974 Apr;67(4):606-11. No abstract available.

  PMID: 4818537 BACKGROUND

• Marchetti GP, Pinelli V, Tassi GF. 100 years of thoracoscopy: historical notes. Respiration. 2011;82(2):187-92. doi: 10.1159/000326066. Epub 2011 Apr 8.

  PMID: 21474917 BACKGROUND

• Shamsuddin AR, Mohamad Jailaini MF, Azmel AA, Abdul Hamid MF. Comparison of diagnostic yield and complication of medical thoracoscopy using Flexible Bronchoscope versus Semi-Rigid Pleuroscope among Hospitalized Patients with Pleural Effusion (FLEXPLEUR): a retrospective observational study. J Thorac Dis. 2025 Jun 30;17(6):3631-3642. doi: 10.21037/jtd-2025-135. Epub 2025 Jun 9.

  PMID: 40688315 BACKGROUND

• Manoharan A, Argaez C. Pleuroscopy for the Diagnosis of Cancer in Patients with Pleural Effusion: A Review of the Diagnostic Accuracy, Safety, Cost-Effectiveness and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2020 Apr 16. Available from http://www.ncbi.nlm.nih.gov/books/NBK563003/

  PMID: 33074637 BACKGROUND

• Loddenkemper R, Boutin C. Thoracoscopy: present diagnostic and therapeutic indications. Eur Respir J. 1993 Nov;6(10):1544-55.

  PMID: 8112449 BACKGROUND

• Boutin C, Cargnino P, Viallat JR. Thoracoscopy in the early diagnosis of malignant pleural effusions. Endoscopy. 1980 Jul;12(4):155-60. doi: 10.1055/s-2007-1021734. No abstract available.

  PMID: 7398596 BACKGROUND

• Menzies R, Charbonneau M. Thoracoscopy for the diagnosis of pleural disease. Ann Intern Med. 1991 Feb 15;114(4):271-6. doi: 10.7326/0003-4819-114-4-271.

  PMID: 1987873 BACKGROUND

• Yokoyama T, Toda R, Tomioka R, Aizawa H. Medical Thoracoscopy Performed Using a Flexible Bronchoscope Inserted through a Chest Tube under Local Anesthesia. Diagn Ther Endosc. 2009;2009:394817. doi: 10.1155/2009/394817. Epub 2009 Jun 7.

  PMID: 19536345 BACKGROUND

• Davidson AC, George RJ, Sheldon CD, Sinha G, Corrin B, Geddes DM. Thoracoscopy: assessment of a physician service and comparison of a flexible bronchoscope used as a thoracoscope with a rigid thoracoscope. Thorax. 1988 Apr;43(4):327-32. doi: 10.1136/thx.43.4.327.

  PMID: 3406921 BACKGROUND

• Fielding D, Hopkins P, Serisier D. Frozen section of pleural biopsies at medical thoracoscopy assists in correctly identifying benign disease. Respirology. 2005 Nov;10(5):636-42. doi: 10.1111/j.1440-1843.2005.00761.x.

  PMID: 16268918 BACKGROUND

• Valsecchi A, Arondi S, Marchetti G. Medical thoracoscopy: Analysis on diagnostic yield through 30 years of experience. Ann Thorac Med. 2016 Jul-Sep;11(3):177-82. doi: 10.4103/1817-1737.185755.

  PMID: 27512506 BACKGROUND

• Collins TR, Sahn SA. Thoracocentesis. Clinical value, complications, technical problems, and patient experience. Chest. 1987 Jun;91(6):817-22. doi: 10.1378/chest.91.6.817.

  PMID: 3581930 BACKGROUND

• Maskell NA, Butland RJ; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the investigation of a unilateral pleural effusion in adults. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii8-17. doi: 10.1136/thorax.58.suppl_2.ii8. No abstract available.

  PMID: 12728146 BACKGROUND

• Rahman NM, Ali NJ, Brown G, Chapman SJ, Davies RJ, Downer NJ, Gleeson FV, Howes TQ, Treasure T, Singh S, Phillips GD; British Thoracic Society Pleural Disease Guideline Group. Local anaesthetic thoracoscopy: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii54-60. doi: 10.1136/thx.2010.137018. No abstract available.

  PMID: 20696694 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, Malignant; Myeloproliferative Disorder, Chronic, with Eosinophilia; Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Mohamed Faisal Abdul Hamid, MBBS(IIUM)

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Faisal Abdul Hamid, MBBS(IIUM)

CONTACT

+603-91456082; faisal.hamid@hctm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigational Product: The investigational device evaluated in this study is the UE Medical Single-Use Flexible Bronchoscope, a sterile disposable flexible endoscope equipped with a 2.8-mm working channel. The device is designed to visualize the pleural cavity and permit pleural tissue sampling with standard biopsy forceps during medical thoracoscopy. Comparator (Standard of Care) The comparator device is the Olympus LTF-260 Semi-Rigid Pleuroscope, which represents the current standard-of-care instrument used for medical thoracoscopy at Hospital Canselor Tuanku Muhriz (HCTM) UKM. The semi-rigid pleuroscope features a flexible distal tip and a 2.8-mm working channel, enabling visualization of the pleural cavity and tissue acquisition during pleural biopsy. The primary difference is that the investigational device is a single-use, disposable, flexible bronchoscope, whereas the comparator is a reusable, semi-rigid pleuroscope routinely used in clinical practice.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)